MedTrace Logo

Observational Prospective Study on Patients With Symptomatic Uterine Fibroids Treated With VizAblate® Intrauterine-ultrasound Guided RF Ablation

NCT01998854 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 4

Last updated 2015-03-11

No results posted yet for this study

Summary

Study is intended to evaluate the one-year safety and clinical status of patients treated for symptomatic uterine fibroids with the VizAblate Intrauterine-ultrasound guided radio frequency (RF) ablation system. Particular attention will be directed to recording safety outcomes including incidence of uterine cavity synechiae. In addition, information on quality of life will be collected.

Overall study duration (first patient enrolled through last patient exit) will be comprised of approximately 12 months of patient enrollment up to 1 month for scheduling of treatment, and 12 months of follow-up, for a total duration of up to 25 months. Study duration for an individual patient, once enrolled, will be approximately 1 month for baseline observations and treatment scheduling, and 12 months for follow up after treatment for a total duration of approximately 13 months.

Conditions

  • Menorrhagia
  • Leiomyoma
  • Uterine Fibroids
  • Uterine Fibroma
  • Uterine Neoplasms

Interventions

DEVICE

VizAblate System

The VizAblate System is indicated for use in transcervical intrauterine-guided radio frequency ablation of uterine fibroids

Sponsors & Collaborators

  • Gynesonics

    lead INDUSTRY

Principal Investigators

  • David Toub, MD · Gynesonics

Eligibility

Min Age
28 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-06-30
Completion
2015-01-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01998854 on ClinicalTrials.gov